Trial · NCT00835575
15 mg Mirtazapine Orally Disintegrating Tablets, Fasting
NCT00835575, Phase 1, Completed, Teva Pharmaceuticals USA; results first posted 2009-08-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 15 mg Mirtazapine Orally Disintegrating Tablets, Fasting. Trials, record NCT00835575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00835575
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 15 mg Mirtazapine Orally Disintegrating Tablets, Fasting
- NCT number
- NCT00835575
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Teva Pharmaceuticals USA
- Conditions
- Healthy
- Interventions
- Mirtazapine 15 mg (Orally Disintegrating) Tablets, REMERON SolTab® 15 mg Orally Disintegrating Tablets
- First posted
- 2009-02-03
- Last updated
- 2024-08-20
- Results first posted
- 2009-08-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | Blood samples collected over a 120 hour period. | Bioequivalence based on Cmax. |
| Primary | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Blood samples collected over a 120 hour period. | Bioequivalence based on AUC0-t. |
| Primary | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | Blood samples collected over a 120 hour period. | Bioequivalence based on AUC0-inf. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | Blood samples collected over a 120 hour period. | All participants that completed the study had their samples analyzed. | pg/mL | MEAN |
| PRIMARY | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Blood samples collected over a 120 hour period. | All participants that completed the study had their samples analyzed. | pg*h/mL | MEAN |
| PRIMARY | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | Blood samples collected over a 120 hour period. | All participants that completed the study had their samples analyzed. | pg*h/mL | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | Test (Mirtazapine) | 32975.95 | Standard Deviation 11873.83 | pg/mL | |
| Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | Reference (Remeron®) | 33122.52 | Standard Deviation 11246.45 | pg/mL | |
| AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Test (Mirtazapine) | 303749.52 | Standard Deviation 104877.35 | pg*h/mL | |
| AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Reference (Remeron®) | 294920.42 | Standard Deviation 105344.06 | pg*h/mL | |
| AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | Test (Mirtazapine) | 327022.65 | Standard Deviation 109980.75 | pg*h/mL | |
| AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | Reference (Remeron®) | 316863.06 | Standard Deviation 111509.8 | pg*h/mL |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Test (Mirtazapine) First | 16 | |
| First Intervention | STARTED | Reference (Remeron®) First | 16 | |
| First Intervention | COMPLETED | Test (Mirtazapine) First | 16 | |
| First Intervention | COMPLETED | Reference (Remeron®) First | 16 | |
| First Intervention | NOT COMPLETED | Test (Mirtazapine) First | 0 | |
| First Intervention | NOT COMPLETED | Reference (Remeron®) First | 0 | |
| Washout of 14 Days | STARTED | Test (Mirtazapine) First | 16 | |
| Washout of 14 Days | STARTED | Reference (Remeron®) First | 16 | |
| Washout of 14 Days | COMPLETED | Test (Mirtazapine) First | 15 | |
| Washout of 14 Days | COMPLETED | Reference (Remeron®) First | 16 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00835575
GET https://conductscience.org/api/trials/v1/NCT00835575/registered